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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2026-05-19

No results posted yet for this study

Summary

The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:

* What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET
* What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

Conditions

  • HR+ Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
  • CCNE1 Amplified Advanced Solid Tumors
  • HR+ HER2- Breast Cancer

Interventions

DRUG

NKT5097 CDK2/CDK4 dual degrader

NKT5097 will be distributed in tablet form and dosed daily or twice a day

DRUG

Fulvestrant

Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.

DRUG

Letrozole

Letrozole will be administered orally once daily.

Sponsors & Collaborators

  • NiKang Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07029399 on ClinicalTrials.gov